Last reviewed · How we verify
NCT05223569
Home Monitoring of Diabetic Macular Edema
NA trial testing Home OCT monitoring model in Macular Edema Due to Diabetes Mellitus in 120 participants. Status unknown.
12 December 2023
Quick facts
| Lead sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 3 March 2022 |
| Primary completion | 12 December 2023 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Home OCT monitoring model
- Hospital-based monitoring with a staff-administrated OCT
Conditions studied
- Macular Edema Due to Diabetes Mellitus — all drugs for Macular Edema Due to Diabetes Mellitus →
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Who can join
18 and older, any sex, with Macular Edema Due to Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diabetic macular edema (DME) is part of diabetic retinopathy (DR) and a leading cause of central visual loss in people with diabetes . Most patients require pharmacological inhibition using anti-vascular endothelial growth factor (VEGF) agents with multiple monitoring visits that include optical coherence tomography (OCT), visual acuity test, and multiple injections.The substantial visit frequency puts pressure on ophthalmic clinics, and can impose a tremendous burden on both patients and their caregivers. Therefore, self-service examination instruments that can be portable and fast-moving become the key for realizing tele-medicine. Recently, the investigators have developed a portable, self-administrated home OCT machine, which is designed for home-based OCT scanning and monitoring for patients with retinal diseases including DME, age related macular degeneration (AMD) and choroidal neovascularization (CNV) that require multiple anti-VEGF injections. The investigators have confirmed its image quality and validated the retinal thickness measurements obtained from this device by comparing with hospital OCT (staff-administrated and clinic-based).In this study, the investigators will conduct a randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a home OCT monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-VEGF injections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05223569
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Zhongshan Ophthalmic Center, Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07524725 — Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on · NA · not yet recruiting
- NCT07096622 — Efficacy of Visual and Perceptual Training on Visual Function for Operative Congenital Ectopia Lentis Children · NA · not yet recruiting
- NCT06098677 — Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects · NA · not yet recruiting
- NCT07512115 — The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surg · NA · not yet recruiting
- NCT07512089 — Comparison of PRESBYOND Laser Blended Vision and Conventional Monovision LASIK in Individuals With Presbyopia: A Randomi · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05223569 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhongshan Ophthalmic Center, Sun Yat-sen University
- Last refreshed: 4 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05223569.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing